Gloucester, MA

Company Name:Helix MedicalHelix Medical is making a world of difference... all around the world.As a global leader in medical contract manufacturing we offer the following services for medical device, pharmaceutical and IVD clients worldwide: silicone and thermoplastic molding.For nearly 30 years, medical device and healthcare companies around the world have looked to Helix Medical to make a difference as the custom manufacturer medical industry leaders can trust. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms.We are currently hiring for a Sr. Process Engineer/Specialist Advanced Injection Molding who is:Hands-on in a dynamic small shop environment where everyone is challenged by rolling up their sleeves to develop and implement solutions for our customer.Providing troubleshooting skills and trains shop floor personnel in problem solving methodology (Medical Device experience not required).Responsible to implement continuous improvement on the Production Floor and support the flawless launch of new products to production through the development, validation of new tools and processesSelf-motivated and thrives in a fast paced, cutting-edge, lean systems environment, where priorities can often change on a daily basis.Basic ResponsibilitiesResponsible for all New and Existing Injection Molding Processes/Equipment and related Efficiency, Uptime, and Scrap Metrics for 24/5 OperationsIdentifies and initiates projects to improve productivity and reduce scrap/reject rates through the implementation of Process Control, Automation, or Tool ModificationsTrains production personnel on process enhancements and troubleshooting methodologySupports Production Floor in identifying root cause, and corrective action implementation of daily Production Related issues across all three shiftsMaintains complete and accurate records of assigned project activities per the established Quality System.Participates as a team member on assigned projects using established APQP Project Management tools - Advises management of any cost related issues for assigned projects makes recommendations to optimize mold/part design as requiredSupports the Validation of all new products into Production by running DOEs, Process Capability Studies, Gauge R&R, Gate Seal-Off, and Material Viscosity StudiesGenerates and maintains documentation for all internal processes, inspection criteria, Bill of Materials and other manufacturing and quality recordsInterfaces with customers and suppliers on project matters as requiredAids with short- and long-term planning for capital expenditures relating to future production requirements; leads projects involving new capital implementationMaintain a vigilance to identify new potential technologies for the company.Conduct internal audits and assists with maintaining the Quality System to ISO-13485 standards.Maintains adherence to company policies, safety/ergonomic standards, and good housekeeping practicesAbility to support Production and New Business needs on Off-Shift and Weekends as requiredRequired QualificationsBachelor of Science degree in Engineering, preferably Plastics Engineering or Technology with a minimum 5 years of experience working as an Injection Molding Process EngineerHigh School Diploma with 20+ years of experience working as an Injection Molding Process SpecialistScientific injection molding backgroundTechnical experience in Injection Molding processes, material behavior and mold design for mold abilityExperience programming/troubleshooting/installing automationProven success at setting and achieving ambitious goals while having a sense of urgency with regard to key initiatives Exceptional follow-up skills and attention to detail neededExperience writing procedures, work instructions, and other related documentsPrevious experience in managing multiple projects simultaneouslyLead by example in performance and behaviorDemonstrated excellent oral, written and computer skills, and presentation skills Microsoft Office Suite competency (Excel, Word, Power Point)Familiarity with statistical problem solving techniquesWorking knowledge of validation (IQ/OQ/PQ)Proven success at managing cost budget and achieving financial justification for Capital PurchasesPrevious experience working in a small manufacturing environmentPreferred Qualifications:Experience with Injection Molding of siliconePrevious experience in a manufacturing environment of medical or healthcare products and familiarity with ISO-13485 and FDA CFR 21 regulationsSix Sigma Green Belt or Black Belt certificationIts an exciting time to work at Helix Medical. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make Helix Medical the employer of choice in this industry. We offer a competitive salary plus a full range of benefits including medical, dental and vision insurance, as well as 401K Match. Learn more at www.helixmedical.com/careers.To Apply:Candidates meeting these qualifications should complete the online application: https://freudenberg-jobs.dvinci.de/cgi-bin/appl/selfservice.pl?action=startapp;job_pub_nr=1406361A-E083-43EA-B31D-A60B7C589C76;p=homepage_com;job_pub_type=externHelix Medical is an Equal Employment Opportunity Employer.

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